Posts tagged Compliance Policy Guide 400.400.
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After Decades of Broad Enforcement Discretion, FDA Signals New Approach to Homeopathic Drugs
Categories: Agency Information, FDA
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Two announcements made by FDA in late October signal a marked change to FDA’s regulatory approach to “homeopathic” drugs. On October 25, 2019, FDA withdrew the 1988 Compliance Policy Guide (“CPG”) 400.400 Conditions Under Which Homeopathic Drugs May Be Marketed, and, concurrently, published revised draft guidance titled Drug Products Labeled as Homeopathic (the “Revised Homeopathic Draft Guidance”).

Homeopathy—an alternative medical approach that began in the late 18th century—is based on the belief that (1) a substance that causes symptoms in a healthy ...

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